Feasibility Study of SPEEDI (SPEEDI)
Primary Purpose
Premature
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SPEEDI
Sponsored by
About this trial
This is an interventional treatment trial for Premature focused on measuring Premature, Development, Motor, Cognitive, Parent
Eligibility Criteria
Inclusion Criteria:
- infants born preterm at 34 weeks Post Menstrual Age (PMA) or less
- medically stable,
- off ventilator support,
- demonstrate thermoregulation in an open crib by 35 weeks of PMA,
- live within 60 minutes of the hospital, and
- have one parent who is English speaking and willing to participate in the study intervention and assessments
Exclusion Criteria:
- genetic syndrome or
- musculoskeletal deformity
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention group
Arm Description
Usual care
Intervention with SPEEDI
Outcomes
Primary Outcome Measures
Test of Infant Motor Performance
Assessment of motor development
Problem Solving Behaviors
Early infant problem solving
Reaching
Reaching and object interaction measures
Secondary Outcome Measures
Parent Child Interactions
Behavioral coding of parent child interactions
Full Information
NCT ID
NCT01889108
First Posted
June 13, 2013
Last Updated
August 21, 2023
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT01889108
Brief Title
Feasibility Study of SPEEDI
Acronym
SPEEDI
Official Title
Feasibility Study of Supporting Play, Exploration, & Early Development Intervention (SPEEDI) for Infants Born Preterm
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The proposed feasibility study will evaluate the investigators ability to conduct a clinical trial of a novel intervention (SPEEDI) which addresses a striking gap in the literature. Supporting Play, Exploration, and Early Development Intervention (SPEEDI) differs from current early intervention practices in 2 important ways. First it bridges the traditional gap in services from the Neonatal Intensive Care Unit (NICU) to home providing ongoing and intensive support for developmental activities when parents are establishing care giving routines. Second, in contrast to wide-ranging intervention provided by current early intervention models, SPEEDI uses an action perception model to target specific behaviors which lead to improved early motor abilities and provide a foundation for learning.[6] The purpose of this feasibility study is to extend the investigators preliminary data and evaluate the feasibility of conducting a randomized control trial to evaluate the efficacy of SPEEDI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature
Keywords
Premature, Development, Motor, Cognitive, Parent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Intervention with SPEEDI
Intervention Type
Behavioral
Intervention Name(s)
SPEEDI
Other Intervention Name(s)
Developed for this study
Intervention Description
Behavior intervention combining parent education and physical therapy intervention for preterm infants
Primary Outcome Measure Information:
Title
Test of Infant Motor Performance
Description
Assessment of motor development
Time Frame
Change from baseline to the end of intervention at 3 months of adjusted age
Title
Problem Solving Behaviors
Description
Early infant problem solving
Time Frame
end of intervention at 3 months of adjusted age
Title
Reaching
Description
Reaching and object interaction measures
Time Frame
end of intervention at 3 months of adjusted age
Secondary Outcome Measure Information:
Title
Parent Child Interactions
Description
Behavioral coding of parent child interactions
Time Frame
End of intervention at 3 months of adjusted age
10. Eligibility
Sex
All
Maximum Age & Unit of Time
34 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
infants born preterm at 34 weeks Post Menstrual Age (PMA) or less
medically stable,
off ventilator support,
demonstrate thermoregulation in an open crib by 35 weeks of PMA,
live within 60 minutes of the hospital, and
have one parent who is English speaking and willing to participate in the study intervention and assessments
Exclusion Criteria:
genetic syndrome or
musculoskeletal deformity
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
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Feasibility Study of SPEEDI
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